Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Interventional
Phase 3
Servier Bio-Innovation LLC (Voir sur ClinicalTrials)
juillet 2024
novembre 2030
02 mars 2026
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind,
randomized, placebo-controlled study of orally administered ivosidenib. Participants are
required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1
(IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1,
2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined
during pre-screening/screening phase. Participant must have radiographic
progression/recurrence of disease according to Response Evaluation Criteria in Solid
Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the
advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is
progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints
are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2
participants, and OS in all randomized participants.
Participants who meet enrollment criteria will be randomized 1:1 to receive oral
ivosidenib 500mg once daily, or a matching placebo once daily.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin VERRET | 27/07/2026 07:00:12 | Contacter | ||
Critères
Tous
- Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected
within the last 3 years) consistent with locally advanced or metastatic conventional
chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
- Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1.
Participants who have received prior radiation therapy are eligible provided
measurable disease falls outside of the treatment field or within the field and has
shown ≥20% growth in size since post-treatment assessment.
- Have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic
setting for chondrosarcoma.
- Have radiographic progression/recurrence of disease according to RECIST v1.1 defined
as:
1. Radiographic progression of disease (local and/or distant) documented by 2
imaging assessments performed no more than 6 months (±2 weeks) apart within 12
months before randomization.
OR
2. Any recurrence of disease (local and/or distant) after complete surgical
resection and documented by imaging within 6 months (±2 weeks) before
randomization.
- Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most
recent banked tumor tissue available that was sourced from either a primary or
metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation
variants tested)
- Have recovered from any clinically relevant sequelae and toxic effects of any prior
surgery, radiotherapy, or other therapy intended for the treatment of cancer.
Exclusion Criteria:
- Are unable to swallow oral medication.
- Pregnant or lactating women.
- Are participating in another interventional study at the same time; participation in
noninterventional registries or epidemiological studies is allowed.
- Have received prior therapy with an IDH1 inhibitor
- Have received systemic anticancer therapy <2 weeks prior to randomization (for
investigational or immune-based anticancer therapy <4 weeks).
- Have received radiotherapy <2 weeks prior to randomization.
- Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone
(or equivalent). Participants with previously diagnosed brain metastases are
eligible if they have completed their treatment and have recovered from the acute
effects of radiation therapy or surgery prior to randomization, have discontinued or
reduced corticosteroid treatment <=10 mg per day for these metastases for at least 4
weeks and have radiographically stable disease of brain lesions for at least 3
months prior to randomization.
- Have a history of another primary cancer, with the exception of: a) curatively
resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c)
pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primary
solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the
opinion of the Investigator, the disease will not affect participant's outcome in
the setting of current chondrosarcoma diagnosis.
- Have had major surgery within 4 weeks prior to randomization.
- Have significant active cardiac disease within 6 months prior to randomization,
including New York Heart Association (NYHA) Class III or IV congestive heart
failure; myocardial infarction; unstable angina; and/or stroke.
- Have LVEF <40% by ECHO scan (or by other methods according to institutional
practice) obtained within 28 days prior to randomization.
- Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450
msec or other factors that increase the risk of QT prolongation or arrhythmic events
(eg, heart failure, hypokalemia, family history of long QT interval syndrome).
Participants with a bundle branch block combined with a prolonged QTcF interval may
be permitted based on local cardiology assessment.
- Have known medical history of progressive multifocal leukoencephalopathy (PML).